Bodily fluids are collected for various reasons, including diagnosing illness, simple therapeutic removal, determining pregnancy, confirming or establishing levels of therapeutic agents, determining drug abuse, and profiling DNA composition. Blood, urine, and saliva are among the commonly collected bodily fluids for some or all of these purposes.
Collecting blood and urine is routine in health care environments for any of the aforementioned reasons. However, collecting these fluids has some negative characteristics for some purposes such as, for example, determining drug abuse, especially in environments outside of traditional health care settings.
Screening for drugs of abuse is performed by health professionals, law enforcement personnel, and government or private employers, among others. Sample collection occurs in numerous different venues, including roadside stops, corporate offices, clinical labs, medical clinics, and in donors' homes. These venues are commonly classified as in-home, point-of-care, or laboratory. Substances of abuse that are commonly screened for include alcohol, cannabis, barbiturates, opioids, cocaine, amphetamines, and hallucinogens.
Obtaining a blood sample requires vascular access with a venipuncture needle, which is highly invasive and potentially dangerous to both donor and administrator. Urine, although less invasive to obtain than blood, brings up issues of privacy that limit its usefulness for drug testing in many environments. Moreover, urine samples are more easily adulterated if continuous donor observation is prevented by privacy requirements. For many such tests and testing environments, blood or urine collection is difficult, if not impossible, making saliva collection an appealing alternative. Saliva is less invasive to obtain than either blood or urine, and does not invoke privacy concerns to the same extent as does urine.
DNA testing is used for purposes of paternity, genealogy, disease susceptibility, and forensics, among others. Blood samples, buccal swabs, and saliva are commonly used for DNA tests. Collecting saliva is less invasive than collecting blood, and saliva collection can provide a larger, and therefore perhaps more reliable sample than buccal swabs.
Saliva samples are commonly collected by one of two methods: intra-oral sponge absorption and direct expectoration. An example of the first is U.S. Pat. No. 4,580,577 to O'Brien, et al, which discloses an absorbent mass that is masticated by the donor until saturated. The mass is placed in a squeezing device to expel saliva into a holding chamber, out of which a test aliquot can be removed. Sponge or sponge-like absorption methods are disclosed in numerous other patents, teaching variations such as added reagents, salivation promoters, preservatives, flavorings, chemical stabilizers, and a plurality of samples, among others.    U.S. Pat. No. 4,817,632 to Schramm    U.S. Pat. No. 5,339,829 to Thieme, et al.    U.S. Pat. No. 5,260,031 to Seymour    U.S. Pat. No. 5,393,496 to Seymour    U.S. Pat. No. 5,981,293 to Charlton    U.S. Pat. No. 6,150,178 to Cesarczyk, et al.    U.S. Pat. No. 6,416,715 to Gambert, et al.    U.S. Pat. No. 7,114,403 to Wu, et al.    U.S. Pat. No. 7,374,723 to Wuske, et al.    U.S. Pat. No. 7,387,899 to D'Angelo    U.S. Pat. No. 7,544,324 to Tung, et al.    U.S. Pat. No. 7,850,922 to Gallagher, et al.    U.S. Patent App. No. 20090117665 to Tung, et al.    U.S. Patent App. No. 20060057027 to Hudak, et al.are some examples of prior art saliva absorption patents.
An example of a commercially available saliva collector using intra-oral absorption is the Salivette® made by Sarstedt AG & Co. The donor removes a cylindrical cotton or synthetic swab from the tube-like container, inserts the swab into the mouth, chews it until it becomes saliva-saturated, then returns it to the tube. A cap is applied that seals the saliva inside the tube.
An example of a sample collection device based on direct expectoration is disclosed in U.S. Pat. No. 3,518,164 to Andelin, et al. This device includes a tube-like collector, an attached funnel, a stabilizing base, and a threaded sealing cap. The donor spits into the funnel, saliva collects in the tube to the desired volume, the funnel is removed, and the donated sample is sealed with the cap.
Other prior art example patents teaching variations of direct saliva expectoration collection include:    U.S. Pat. No. 4,741,346 to Wong, et al.    U.S. Pat. No. 4,283,498 to Schlesinger    U.S. Pat. No. 4,589,548 to Fay    U.S. Pat. No. 4,761,379 to Williams, et al.    U.S. Pat. No. 4,768,238 to Kleinberg, et al.    U.S. Pat. No. 4,932,081 to Bums    U.S. Patent App. No. 200500965693 to Liang U.S.    Patent App. No. 20090216213 to Muir et al.